K223905
- 510(k) number
- K223905
- Device name
- Vivio® LVEDP System
- Applicant
- Avicena, LLC CA · US
- Product code
- QUO — Adjunctive Heart Failure Status Indicator
- Decision date
- 2023-10-06
- Date received
- 2022-12-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K223905.pdf
Official FDA record: K223905
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.